Kenneth M. Kilborn
Continuous Improvement Manager
Certified Lean Six Sigma Advanced Master Black Belt, Project Management, Manufacturing, Operations and Engineering Professional. Successfully worked with numerous companies to optimize manufacturing, operational, organizational and product design, engineering, manufacturing and NPI processes. Strengths include: Project Management, Day to Day Manufacturing, Operations Management, and Engineering Management, effectively identifying process, business and operational improvement opportunities. Lean six sigma teaching and mentoring along with operations best practices. Forming and directing cross functional teams.
My skill- set includes:
Continuous Improvement Mindset
Manufacturing and Engineering best practices (cGMP, FDA 21 CFR 820, ISO 13485)
Management Best Practices
New Product Introduction
Project Management (Track and manage multiple projects)
Extensive business and analytics, clear problem statement development, and a wealth of analytical tools associated with the methodology
Process development and creating a continuous improvement mindset (Process Capability)
Master of Business Administration (MBA)
Angelo State University – School of Business – San Angelo, TX
Bachelor of Science in Biomedical Engineering
Boston University – College of Engineering – Boston, Ma
Lean Six Sigma Advance Master Black Belt Certification
VILC146307 Certification from Villanova University
Mattson Technology, Fremont, CA Apr 2018 – Present
Contract Position to design and improve specific Plant Operations (Semiconductor Industry)
Project Manager ISO 9001:2015 ISO Audit
Project Manager for implementing a new Manufacturing Execution System (MES)
Continuous improvements in supply chain (cost cutting) and Manufacturing Engineering
Shipping and Receiving improvements
Create operations current and future state value stream maps
Prepare and communicate plans for improvement to executive staff
Angelica, Pittsburg, CA Nov 2017 – Apr 2018
Plant Manager / Plant Operations Director
(Hospital Services Company)
Created and managed a Continuous Improvement Program and rolled out throughout the facility
Responsible for all Plant Functions including:
Responsible for $15MM+ monthly revenue generation
Handled all Financial Data
Defined and had Oversight for all projects initiated for process improvements.
Led the efforts to improve Engineering and Maintenance practices.
Responsible for overall plant financials, capital and expense budgets, and Profit and Loss (P&L).
Responsible for improvements and oversight of Logistics, Manufacturing, EH&S and Facilities activities
Owner for all Quality for the facility
Phoenix Technology Group, Pleasanton, CA June 2016 – Oct 2017
Vice President of Operations and Manufacturing
(Medical Device & Life Science Company)
Directed a Continuous Improvement Program within Manufacturing
Designed, built and validated process for new medical devices (Concept through launch/post-launch).
New Product Design and Introduction (NPI)
Project Management (cGMP, FDDA, ISO 13485)
Design and Document Control
Accountable for all Operations functions
Interim Regulatory and Quality Director
Kilborn & Associates: Business Process Excellence LLC Pleasanton, CA Jan 2013 – June 2016
Engineering/ Lean Six Sigma/Operations/Manufacturing -Principal
Focused on Project Management, Validation, Safety, Process efficiencies, effectiveness and developing a continuous improvement environment for the following short-term contract assignments.
Genentech Research and Early Development of Drugs (gRED) Analyst (New Product Introduction, Risk Management and Process Improvements)
Led team to roll-out new software for clinical trials flow qand data collectiion
Worked on new help desk roll out
Medtronic: Covidien – Reverse Medical-Medtronic
Process Improvement Sr. Project Manager, Quality Lead for neurovascular stent Improvements.
Lead team to determine product failure modes
Lead team to design new manufacturing techniques for stent manufacturing
Lean Six Sigma Implementation/Instruction/Project Management
Taught and mentored Lean Six Sigma
Project manager for a specific regulatory project
Project Manager for developing Master Validation Plan
Hardin California MC
General Manager for failed business (bankrupt), to grow back to life by leading the engineering, manufacturing, and quality teams to develop clear and crisp goals and objectives along with timeline details. The business sold.
BIO-RAD LABORATORIES, Hercules, California June 2006 – Oct 2013
Medical technology manufacturer and distributor.
Manufacturing Engineering Manager (Process Excellence Focus) and Validation Engineering Manager
Department Head for two departments, Manufacturing/Process Engineering and Validation Engineering (12 Engineers and Scientist direct reports), utilizing Lean Six Sigma and operations management experience to select, prioritize and allocate resources in support of new product introductions (NPI), sustaining engineering, validations, and cross functional projects.
Initiated a Continuous Improvement Program that focused on Value Streams and developing Leaders that focused on the initiatives of the company
Initiated Operational Excellence Program, and Chaired Lean Six Sigma Steering Committee (Continuous Improvements). Selected Projects and had oversight
Value Stream Mapped and worked with worldwide manufacturing sites to improve various processes
Ensured compliance with FDA, cGMP and all other applicable regulatory agencies.
Responsible for all site validations within the Clinical Systems Division
Presented progress and results of in-process data through technical reports, analysis, recommendations and presentations to all levels within the organization
Led Cross functional team to improve New Product Introduction (NPI) process.
Mentored belt projects leading to certification
Conducted Lean Six Sigma champions training for all employees, managers and executives in the Clinical Systems Division (Continuous Improvement.
Authored Process Risk Management Standard Operating Procedure used for all process risk assessments and mitigations across all value steams and quality programs.
KYPHON INC (Medtronic). Sunnyvale, California July 2004 – June 2006
(Medical device engineering company)
Rolled out Lean Six Sigma program (Continuous Improvement) company-wide and conducted six sigma training. Had oversight for Lean Six Sigma projects using DMAIC and/or Lean methodologies for improving key business metrics.
Lead cross functional team to improve New Product Introduction Process (NPI)
Documented organizational and process designs through value stream mapping
Trained and mentored Green Belts, nurturing a culture of continuous improvement
Reduced cycle time within the CAPA and NCR processes by 50% and reduced human errors by 50%
Provided hands on leadership for multiple operational initiatives, including improvements in manufacturing yield and uptime for key processes.
Assembled and led teams of subject matter experts (SME’s) through value stream mapping and critical thinking to identify the key areas for improvement
Determined optimal equipment settings for integral production process by conducting Design of Experiments
Johnson & Johnson (2 Companies) Milpitas CA, and San Angelo TX June 1991 – July 2004
Sr. Operations Engineering Manager
Managed Operations Engineering department and led staff in multiple high profile projects.
Leader for project prioritization and continuous improvement activities (Six Sigma Steering committee), including Business and Quality Processes.
Led teams to reduce global quality issues and non-conformances by 80%, field actions by 90% and cut cycle time by 50%.
Technical Leader / Operations Process Leader, San Angelo, TX
Led Tactical decision making for large manufacturing/packaging group with over 500 employees (24 X 7 Operation)
Oversaw department performance and customer service results, as well as developed and administered department budgets
Established key performance indicators and goals in compliance with organizational objectives
Achieved 98% customer fill rate through focus on continuous improvement in manufacturing cycle time, cost per unit, overall process yields, and line efficiencies
Project Manager for high profile project team in $100MM capital budget, for Sterilization Engineering Department; designing installing, and successfully validating a Non-CFC 100% EtO sterilization process
Installed and Commissioned 100% nitrogen filled room with automated sealing equipment, including ability to maintenance equipment without entering sterile room.
Developed PLC control code for process automation and developed HMI interface screens for equipment
Designed, built and validated new automation for sterile suture manufacturing, including automation manufacturing product
Johnson & Johnson Silver and Gold award recipient
Northwestern University: Kellogg Executive Program in Factory Physics:
Radiation and Safety Training from University of Texas (Certificate)
ASQ, ISPE, I Six Sigma
Publications: Harvard Medical School and MIT
Increased Respiratory Frequency and Variability in High Risk Babies Who Die of Sudden Infant Death Syndrome Article in Pediatric Research 22(2):158-62 · September 1987
Analysis of Heart Rate and Respiratory Patterns in Sudden Infant Death Syndrome Victims and Control Infants Article in Pediatric Research 20(7):680-4 · August 1986
Assessment of autonomic function in humans by heart rate spectral analysis Article in American Journal of Physiology 01 JAN 1985.248.1.H151
Microsoft Excel • Microsoft Word • Microsoft Outlook • Minitab • PLC Ladder Logic, Visio
UCSF Medical School
SP teaching advanced Physical Assessment to 1st and 2nd year Medical Students (Sept 2017-April 2018) Occasional weekends
Angelo State University, San Angelo, Texas State University System, Norris-Vincent College of Business
2000 – 2001
Adjunct Professor – Graduate School of Business
Lead Instructor (approx. 30 students) for Production and Operations Management class within MBA program. Class included topics of Organizational Design, Manufacturing Processes, Resource/Production planning and scheduling (ERP), New Product Introduction (NPI), Collective Bargaining, Managerial Accounting, WIP, Process Design & Control, Project Management, and Lean Six Sigma (Operational Excellence)